Arcturus, CSL: EMA OKS Application for ARCT-154 Vaccine to Prevent COVID

 EMA application supported by Phase 3 primary vaccination study demonstrating primary efficacy endpoint was met

An additional Phase 3 booster study demonstrating non-inferiority of immune response compared to Comirnaty® and superiority of ARCT-154 in neutralizing antibody response against SARS-CoV-2 Omicron BA.4/5 variant was shown as a key secondary endpoint

https://www.biospace.com/article/releases/arcturus-therapeutics-and-csl-announce-european-medicines-agency-validates-marketing-authorization-application-for-arct-154-vaccine-to-prevent-covid-19/